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Sankar, Srividya
- Game Changer in the Management of Diabetic Neuropathy: an Indian Perspective - Post-Marketing Surveillance of Epalrestat and Methylcobalamin
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Authors
Affiliations
1 Scientific Department, Aristo Pharmaceuticals Private Limited, Mumbai, IN
1 Scientific Department, Aristo Pharmaceuticals Private Limited, Mumbai, IN
Source
The Indian Practitioner, Vol 66, No 12 (2013), Pagination: 745-750Abstract
Background: Diabetic Neuropathy is one amongst the most common long - term complication of diabetes. It is prevalent in more than 50% of people suffering from diabetes mellitus. Management of diabetic neuropathy is aimed at targeting the pathogenetic factors that leads to neuropathy. Epalrestat helps to prevent neuronal degeneration by reducing the accumulation of toxic sorbitol and decreasing the oxidative stress while methylcobalamin helps to recover neuronal injury.The purpose of this study was to evaluate safety and efficacy of fixed dose combination of Epalrestat+ Methylcobalamin in patients with diabetic neuropathy.Method: A prospective, open-label, non-comparative study was conducted in different regions of India. A pool of 150 patients was involved in the study and the duration of study was 12 weeks. A fixed dose combination of Epalrestat 50 mg + Methylcobalamin 500 mcg three times a day was administered.
Results: At the end of the study, a significant difference was observed in various parameters from baseline. A significant reduction in neuropathic symptoms was observed at the end of the treatment (58% reduction at 4th week and 94% reduction at 12th week). The mean pain intensity score reduced to 89.4% from baseline. A positive effect was also observed in muscle strength that increased to 36% in patients. As per investigator's assessment about efficacy and tolerability, 82.7% of patients reported excellent efficacy and 86.7% of patients reported excellent tolerability. The therapy was well tolerated with few adverse events (AEs).
Conclusion: The results of this study confirm that this combination of Epalrestat+ Methylcobalamin is well tolerated and it showed significant improvement in the symptoms of diabetic neuropathy at the end of treatment.
Keywords
Diabetes Neuropathy, Epalrestat, Methylcobalamin, Polyol Pathway, Aldose Reductase Inhibitor, Diabetes.
- A Review of the Role of Silodosin as Medical Expulsive Therapy for Ureteral Stones
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Authors
Affiliations
1 Aristo Pharmaceuticals Private Limited, Mumbai, IN
1 Aristo Pharmaceuticals Private Limited, Mumbai, IN
Source
The Indian Practitioner, Vol 73, No 9 (2020), Pagination: 25-32Abstract
Urolithiasis is a chronic human condition that has immense public health importance and it poses a tremendous economic burden on our society. Medical expulsive therapy (MET) for the treatment of ureteral stones has emerged as a cost-effective approach. In the last few years, a number of drugs have been introduced and used successfully as MET for the expulsion of small, uncomplicated ureteral calculi. Using a selective α-adrenoceptor blocker for MET has emerged as an effective treatment approach and is widely used for ureteral stones. Silodosin, a selective α-blocker, has a higher selectivity for the α1A receptor as compared to other agents in the class. The objective of this review is to determine the efficacy and safety of Silodosin in MET as compared to placebo and Tamsulosin.Keywords
Ureteral Stone Expulsion, Urolithiasis, alpha-1 adrenoceptor blocker, Silodosin, Tamsulosin.References
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- Itoh Y, Okada A, Yasui T, Ando R, Tozawa K, Sasaki S, Kohri K. Administration of the selective alpha 1A-adrenoceptor antagonist silodosin facilitates expulsion of size 5–10 mm distal ureteral stones, as compared to control. Int Urol Nephrol.2013; 45:675–78.
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- The Journey of Vildagliptin: From Bench to Bedside
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PDF Views:85
Authors
Affiliations
1 President – Medical & Regulatory Affairs, IN
2 Sr. General Manager – Scientific, Scientific Department, IN
3 Dy. Manager – Scientific, Scientific Department, Aristo Pharmaceuticals Private Limited, Mumbai, IN
1 President – Medical & Regulatory Affairs, IN
2 Sr. General Manager – Scientific, Scientific Department, IN
3 Dy. Manager – Scientific, Scientific Department, Aristo Pharmaceuticals Private Limited, Mumbai, IN
Source
The Indian Practitioner, Vol 75, No 4 (2022), Pagination: 28-36Abstract
Vildagliptin, a DPP-4 inhibitor has been available for the management of type 2 diabetes mellitus for more than a decade. The extensive clinical data support from several vildagliptin clinical trials and real-world studies provided the clinicians with an effective treatment option for lowering blood glucose, which neither causes weight gain nor increased the risk of hypoglycemia and cardiovascular events. This article reviews the development journey of vildagliptin from the proof-of-concept of DPP-4 inhibition from its earlystages in the 1990s to the present, being an extensively studied, well-established DPP-4 inhibitor.The article highlights the clinical effectiveness, safety, and tolerability studies of vildagliptin, which proved vildagliptin as an effective and safe option in the armamentarium of type 2 diabetes mellitus management in this era of evidence-based medical practice. This vildagliptin journey, from proof-of-concept to a very well-established molecule gives a lesson that a novel concept takes time and requires focused efforts, persistence, and long-term perseverance for bringing it into clinical practice.
Keywords
Vildagliptin, gliptins, DPP-4 inhibitor, diabetes, glucose lowering therapyFull Text
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